AsthmaNCT00238069
Effect of CPAP (Continuous Positive Airway Pressure) on Lung Function in Asthmatics With Sleep Apnea
A study testing CPAP machine as a result of sleep study in people with Asthma and Sleep Apnea, run by National Jewish Health at 1 site in United States.
Trial summary
This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Sleep Apnea
- What is being tested?
- CPAP machine as a result of sleep study
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18yrs at the time of recruitment)
- Body mass index (BMI) ≥ 30
- Symptoms suggestive of sleep apnea
- Epworth Sleepiness Score (ESS) within range
- Positive sleep study for sleep apnea
Who cannot join
- Tobacco use within the last 3 months.
- Presence of other significant comorbid heart or lung disease
- Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
- Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
- Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
- Presence of severe or uncontrolled sinusitis, such that CPAP therapy will be difficult or uncomfortable.
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- History of significant claustrophobia, uncontrolled psychiatric disease, or anticipated intolerance of CPAP therapy.
- Night shift workers, or other subjects with significantly altered sleep-wake cycles.
- Baseline post-bronchodilator FEV1 < 70% predicted.
- Severe gastroesophageal reflux disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Jewish Medical and Research Center
Denver, Colorado, 80206
About this study
Official title: Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study
This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.
- Conditions
- Asthma, Sleep Apnea
- Being tested
- CPAP machine as a result of sleep study
- Keywords
- Asthma, Sleep Apnea, Obesity, CPAP
- Medical subject headings
- Asthma, Sleep Apnea Syndromes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP machine as a result of sleep studyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.
Endobronchial biopsies to analyze extent and type of inflammatory cell.
Secondary outcomes (3)
Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
Spirometry measured at three time points: before, during, and after CPAP therapy.
Post-CPAP methacholine for bronchial hyperreactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Investigators
- Richard Martin, MD, Principal investigator, National Jewish Medical and Research Center faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238069
- Sponsor's protocol ID
- HS-1866
- Status last verified
- Mar 2017
- First submitted
- 11 Oct 2005
- Last updated
- 29 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP (Continuous Positive Airway Pressure) on Airway Inflammation in Asthmatics With Sleep-Disordered Breathing: A Pilot Study
- ClinicalTrials.gov ID
- NCT00238069
- Acronym / sponsor ID
- HS-1866
- Conditions
- Asthma, Sleep Apnea
- Keywords
- Asthma, Sleep Apnea, Obesity, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 13 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study of asthma and sleep apnea. Our hypothesis is that untreated sleep apnea causes inflammation in the lung, which can worsen asthma. We believe treatment of sleep apnea will reduce this inflammation, and improve asthma control. This study will help us better understand what happens to the lung and bronchial tubes before and after treatment of sleep apnea, which could benefit all patients with sleep apnea. This study involves 2 bronchoscopies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (>18yrs at the time of recruitment)
- Body mass index (BMI) ≥ 30
- Symptoms suggestive of sleep apnea
- Epworth Sleepiness Score (ESS) within range
- Positive sleep study for sleep apnea
Key exclusion criteria (10 listed)
- Tobacco use within the last 3 months.
- Presence of other significant comorbid heart or lung disease
- Presence of another chronic inflammatory disease, such as connective-tissue disease, inflammatory bowel disease, or active infection.
- Use of systemic steroids, as defined as any prednisone use in the preceding 3 months.
- Use of leukotriene antagonists or theophylline within the preceding 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP machine as a result of sleep study | Device | – |
Primary outcome
Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.
Exhaled breath condensate levels of IL-6 and 8-isporostane will be measured.
BAL (bronchial lavage) fluid cell count and differential, IL-6, IL-8, and TNF- α will be measured.
Endobronchial biopsies to analyze extent and type of inflammatory cell.
3 secondary outcomes
Symptoms, albuterol use and daily morning and evening peak expiratory flows from diary cards.
Spirometry measured at three time points: before, during, and after CPAP therapy.
Post-CPAP methacholine for bronchial hyperreactivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Martin, MD principal investigator
National Jewish Medical and Research Center faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP machine as a result of sleep study in people with Asthma and Sleep Apnea, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic inflammatory markers will include IL-6, IL-8, CRP, and TNF-α.. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.